Auriculotherapy Treatment in Fibromyalgia (Fib-Auric)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specific auriculotherapy
non-specific auriculotherapy
seed auriculotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Auriculotherapy
Eligibility Criteria
Inclusion Criteria:
- fibromyalgia (criteria from ACR)
Exclusion Criteria:
- history or existing of inflammatory rheumatims, lupus, systemic diseases that may explain the pain syndrom
- history or existing of severe psychiatric desorder
- history or existing of hemophilia
- with anticoagulant treatment
- local counterindication to auriculotherapy
- valvular prosthesis
- auriculotherapy during the last 12 months
- new psychotherpeutic treatment which interfer with auriculotherapy
- pregnancy
- breath feeding
- RMI for the next 5 months
Sites / Locations
- Hopital Foch
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Placebo Comparator
Arm Label
Specific auriculotherapy
Non-specific auriculotherapy
Seed auriculotherapy
Arm Description
Auriculotherapy on specific points with needles
Auriculotherapy on non-specific auriculotherapy points with needles
Auriculotherapy on non-specific auriculotherapy points with seeds
Outcomes
Primary Outcome Measures
Effect of otherapy on the health of patients with fibromyalgia syndrome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02764788
Brief Title
Auriculotherapy Treatment in Fibromyalgia
Acronym
Fib-Auric
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2016 (Actual)
Primary Completion Date
March 9, 2022 (Actual)
Study Completion Date
March 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, and one of the most frequent causes of referral to the pain management unit. It affects mainly women; they are referred by a rheumatologist, an internal medicine physician or by their family physician.
FM produces various degrees of disability and pain, and has an important impact on quality of life. Sleep disorders, fatigue and cognitive dysfunctions are almost always part of the clinical presentation. The wide range of symptoms and signs, the unknown etiology, the lack of efficacy of pharmacological treatments make management of FM a very difficult task. In France the consensus includes limitation of pharmacological treatment, encouraging physical rehabilitation and referring the patients to a specialized pain clinic where multidisciplinary management will be undertaken. In our hospital the investigators favor non pharmacological therapies and propose to the FM patients to learn relaxation and self-hypnosis, physical rehabilitation and use of trans cutaneous electrical neurostimulation.
Auriculotherapy (AT) is a complementary therapy, based on the idea that the ear is a microsystem which reflects the entire body, represented on the auricle, the outer portion of the ear. Mapping of the auricle has been described, according to the fact that pathology of different organs can induce specific changes in the auricle, for example color change or sensitivity. Treating specific areas, which somehow would be "connected" to the affected organ could also improve the functioning of the body or relieve pain. AT uses placement of needles at points tailored to the patient's pathology. Whatever the mechanisms involved, the effectiveness of ATis currently supported by randomized controlled trials. It is validated by WHO since 1987, mapped in an international nomenclature initially proposed by Nogier.
The investigators regularly use AT in FM patients in our pain management unit to alleviate symptoms as pain, sleep disorders, anxiety. The investigators established a clinical trial in this population to assess impact of FM (assessed with Fibromyalgia Impact Questionnaire) following 3 months of AT management (Primary Outcome). Sleep disorder, fatigue, anxiety and depression, cognitive and physical dysfunction are also evaluated as secondary outcomes. The remnant effect of AT is also evaluated, 3 month after the end of the treatment by the same tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Auriculotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Specific auriculotherapy
Arm Type
Experimental
Arm Description
Auriculotherapy on specific points with needles
Arm Title
Non-specific auriculotherapy
Arm Type
Sham Comparator
Arm Description
Auriculotherapy on non-specific auriculotherapy points with needles
Arm Title
Seed auriculotherapy
Arm Type
Placebo Comparator
Arm Description
Auriculotherapy on non-specific auriculotherapy points with seeds
Intervention Type
Other
Intervention Name(s)
Specific auriculotherapy
Intervention Description
Specific auriculotherapy with needles
Intervention Type
Other
Intervention Name(s)
non-specific auriculotherapy
Intervention Description
non-specific auriculotherapy with needles
Intervention Type
Other
Intervention Name(s)
seed auriculotherapy
Intervention Description
non-specific auriculotherapy with seeds
Primary Outcome Measure Information:
Title
Effect of otherapy on the health of patients with fibromyalgia syndrome
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
fibromyalgia (criteria from ACR)
Exclusion Criteria:
history or existing of inflammatory rheumatims, lupus, systemic diseases that may explain the pain syndrom
history or existing of severe psychiatric desorder
history or existing of hemophilia
with anticoagulant treatment
local counterindication to auriculotherapy
valvular prosthesis
auriculotherapy during the last 12 months
new psychotherpeutic treatment which interfer with auriculotherapy
pregnancy
breath feeding
RMI for the next 5 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireille Michel-Cherqui, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Auriculotherapy Treatment in Fibromyalgia
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